HIV (Human Immunodeficiency Virus)NCT07731932
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
A study testing PNF - HIV norms, PNF - Alcohol use norms and PNF - HIV and alcohol use norms in people with HIV (Human Immunodeficiency Virus) and Alcohol Misuse, run by Vanderbilt University at 1 site in Uganda.
Trial summary
Randomized controlled trial to test the preliminary efficacy and mediating mechanism of a personalized normative feedback intervention on behavioral intentions, heavy alcohol use, and HIV/STI prevention among adolescents and young adults in Rwampara District, Uganda. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Alcohol Misuse, STI
- What is being tested?
- PNF - HIV norms, PNF - Alcohol use norms and PNF - HIV and alcohol use norms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2026to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age
Who cannot join
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Mbarara University of Science and Technology
Mbarara, Uganda
Charles Baguma, MPH, 256-077-564-1558, Cbaguma@mustresearch.org
About this study
Official title: Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools
Randomized controlled trial to test the preliminary efficacy and mediating mechanism of a personalized normative feedback intervention on behavioral intentions, heavy alcohol use, and HIV/STI prevention among adolescents and young adults in Rwampara District, Uganda.
Read the detailed description
New approaches to HIV prevention and treatment among young people in HIV-endemic African countries will be needed to meet the 95-95-95 UNAIDS targets. Several HIV/STI transmission-related behaviors are more likely to occur with heavy alcohol use including engaging in condomless sex, partner concurrency, and transactional sex. Heavy alcohol use is a prevalent and strong modifiable risk factor for HIV transmission risk behavior in Uganda. One way to target behaviors related to HIV/STI-transmission, alcohol misuse, and their intersection is to target misperceived norms, which are directly linked to personal health behavior.
This study employs a randomized controlled trial to evaluate how providing accurate information about local descriptive (i.e., behavioral) and injunctive (i.e., attitudinal) norms to adoloescents and young adults affect HIV/STI transmission behaviors and alcohol misuse. Participants are randomly assigned to one of four treatment arms: (1) a control condition without any normative information; (2) a treatment condition in which they are reminded of what they thought local HIV/STI transmission behavior engagement rates were in their school and then receive accurate information about rates of HIV/STI transmission behavior engagement and prevention in their school; (3) a treatment condition in which they are reminded of what they thought alcohol misuse rates were in their school and then receive accurate information about rates of alcohol misuse behavior in their school; or (4) a treatment condition in which they are reminded of what they thought alcohol misuse rates and local HIV/STI transmission behavior engagement rates were in their school and then receive both types of accurate normative information in their school.
The study assesses how providing this type of personalized normative feedback within cohort-based data collection affects alcohol use and engagement in HIV/STI transmission behaviors, such as condomless sex, transactional sex, and drug/alcohol use during sexual activity. Outcomes will be measured through self-reported data at two time points within 12 months through two follow-up survey waves, which will be compared to baseline self-reported data before exposure to the PNF treatment. We hypothesize that providing accurate information about alcohol misuse and HIV/STI transmission and prevention behavior engagement rates will decrease alcohol misuse, decrease engagement in HIV/STI-transmission behavior and increase prevention behavior (primary outcomes), and improve the accuracy of estimated school level rates of engagement in HIV/STI transmission behaviors and alcohol misuse in the future (secondary outcome).
- Conditions
- HIV (Human Immunodeficiency Virus), Alcohol Misuse, STI
- Being tested
- PNF - HIV norms, PNF - Alcohol use norms, PNF - HIV and alcohol use norms
- Keywords
- HIV transmission, sexually transmitted infections, personalized normative feedback, social norms, HIV prevention, alcohol use
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF - HIV normsBehavioural
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of engagement in HIV-transmission behavior engagement in their school. Participants are then provided with the true rates of HIV-transmission behavior engagement in their school, and notification that this is consistent across demographic groups.
Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol misuse, which will be compared to baseline data collected before treatment.
PNF - Alcohol use normsBehavioural
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of rates of alcohol use in their school. Participants are then provided with information about the true rates of alcohol use in their school.
Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment.
PNF - HIV and alcohol use normsBehavioural
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The fourth treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of HIV transmission behavior engagement and alcohol use in their school. Participants are then provided with information about the true rates of both HIV transmission behavior engagement and alcohol use in their school.
Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: No normative feedback | No intervention | Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version does not provide any normative feedback information. |
| Arm 2: PNF-HIV norms only | Experimental | Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.
This version provides personalized normative feedback with descriptive and injunctive norms information about school level rates of engagement in HIV-transmission and prevention behaviors. Receives: Behavioral: PNF - HIV norms |
| Arm 3: PNF-Alcohol use norms only | Experimental | Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.
This version provides personalized normative feedback with descriptive and injunctive norms information about alcohol use. Receives: Behavioral: PNF - Alcohol use norms |
| Arm 4: PNF-HIV transmission and alcohol use norms | Experimental | Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm.
This version provides personalized normative feedback with both school level descriptive and injunctive norms surrounding alcohol use and engagement in HIV/STI transmission and prevention behaviors. Receives: Behavioral: PNF - HIV and alcohol use norms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported engagement in partner concurrency
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported recent engagement in condomless sex
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in alcohol use
Measured through the participant's self reported AUDIT-C score.
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported HIV testing
Measured: Assessed at 3 months and 9 months after the intervention.
Self-reported alcohol/drug use during sex
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Secondary outcomes (5)
Self-reported engagement in transactional sex
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported PrEP willingness/stigma/interest
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in other sexual behaviors
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported perception of school-level rates of engagement in alcohol use
Measured: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Vanderbilt University Medical Center, University of California, San Francisco, Massachusetts General Hospital, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jessica Perkins, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731932
- Sponsor's protocol ID
- 250304
- Other IDs
- R01AA031936
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be loaded into NIAAA data archive
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools
- ClinicalTrials.gov ID
- NCT07731932
- Acronym / sponsor ID
- 250304
- Conditions
- HIV (Human Immunodeficiency Virus), Alcohol Misuse, STI
- Keywords
- HIV transmission, sexually transmitted infections, personalized normative feedback, social norms, HIV prevention, alcohol use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Vanderbilt University Medical Center, University of California, San Francisco, Massachusetts General Hospital, Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial to test the preliminary efficacy and mediating mechanism of a personalized normative feedback intervention on behavioral intentions, heavy alcohol use, and HIV/STI prevention among adolescents and young adults in Rwampara District, Uganda.
Detailed description
New approaches to HIV prevention and treatment among young people in HIV-endemic African countries will be needed to meet the 95-95-95 UNAIDS targets. Several HIV/STI transmission-related behaviors are more likely to occur with heavy alcohol use including engaging in condomless sex, partner concurrency, and transactional sex. Heavy alcohol use is a prevalent and strong modifiable risk factor for HIV transmission risk behavior in Uganda. One way to target behaviors related to HIV/STI-transmission, alcohol misuse, and their intersection is to target misperceived norms, which are directly linked to personal health behavior.
This study employs a randomized controlled trial to evaluate how providing accurate information about local descriptive (i.e., behavioral) and injunctive (i.e., attitudinal) norms to adoloescents and young adults affect HIV/STI transmission behaviors and alcohol misuse. Participants are randomly assigned to one of four treatment arms: (1) a control condition without any normative information; (2) a treatment condition in which they are reminded of what they thought local HIV/STI transmission behavior engagement rates were in their school and then receive accurate information about rates of HIV/STI transmission behavior engagement and prevention in their school; (3) a treatment condition in which they are reminded of what they thought alcohol misuse rates were in their school and then receive accurate information about rates of alcohol misuse behavior in their school; or (4) a treatment condition in which they are reminded of what they thought alcohol misuse rates and local HIV/STI transmission behavior engagement rates were in their school and then receive both types of accurate normative information in their school.
The study assesses how providing this type of personalized normative feedback within cohort-based data collection affects alcohol use and engagement in HIV/STI transmission behaviors, such as condomless sex, transactional sex, and drug/alcohol use during sexual activity. Outcomes will be measured through self-reported data at two time points within 12 months through two follow-up survey waves, which will be compared to baseline self-reported data before exposure to the PNF treatment. We hypothesize that providing accurate information about alcohol misuse and HIV/STI transmission and prevention behavior engagement rates will decrease alcohol misuse, decrease engagement in HIV/STI-transmission behavior and increase prevention behavior (primary outcomes), and improve the accuracy of estimated school level rates of engagement in HIV/STI transmission behaviors and alcohol misuse in the future (secondary outcome).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: No normative feedback | No intervention | –Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version does not provide any normative feedback information. |
| Arm 2: PNF-HIV norms only | Experimental | Behavioral: PNF - HIV normsEach version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about school level rates of engagement in HIV-transmission and prevention behaviors. |
| Arm 3: PNF-Alcohol use norms only | Experimental | Behavioral: PNF - Alcohol use normsEach version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about alcohol use. |
| Arm 4: PNF-HIV transmission and alcohol use norms | Experimental | Behavioral: PNF - HIV and alcohol use normsEach version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with both school level descriptive and injunctive norms surrounding alcohol use and engagement in HIV/STI transmission and prevention behaviors. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age
Key exclusion criteria (1 listed)
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF - HIV normsAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of engagement in HIV-transmission behavior engagement in their school. Participants are then provided with the true rates of HIV-transmission behavior engagement in their school, and notification that this is consistent across demographic groups. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol misuse, which will be compared to baseline data collected before treatment. | Behavioural | Arm 2: PNF-HIV norms only |
| PNF - Alcohol use normsAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of rates of alcohol use in their school. Participants are then provided with information about the true rates of alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. | Behavioural | Arm 3: PNF-Alcohol use norms only |
| PNF - HIV and alcohol use normsAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The fourth treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of HIV transmission behavior engagement and alcohol use in their school. Participants are then provided with information about the true rates of both HIV transmission behavior engagement and alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. | Behavioural | Arm 4: PNF-HIV transmission and alcohol use norms |
Primary outcome
Self-reported engagement in partner concurrency
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported recent engagement in condomless sex
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in alcohol use
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Measured through the participant's self reported AUDIT-C score.
Self-reported HIV testing
Time frame: Assessed at 3 months and 9 months after the intervention.
Self-reported alcohol/drug use during sex
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
5 secondary outcomes
Self-reported engagement in transactional sex
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported PrEP willingness/stigma/interest
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported engagement in other sexual behaviors
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Self-reported perception of school-level rates of engagement in alcohol use
Time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be loaded into NIAAA data archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF - HIV norms, PNF - Alcohol use norms and PNF - HIV and alcohol use norms in people with HIV (Human Immunodeficiency Virus) and Alcohol Misuse, run by Vanderbilt University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica M. Perkins, Ph.D. (585-750-6694, jessica.m.perkins@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported engagement in partner concurrency (time frame: Assessed at 3 months and 9 months after the intervention via follow-up survey.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.